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Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians (flixovate HAS)

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ClinicalTrials.gov Identifier: NCT01920464
Recruitment Status : Completed
First Posted : August 12, 2013
Last Update Posted : September 15, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief Summary:

this study has been request by french health authorities to evaluate the use of flixovate in infants and its place in the treatment pathway.

this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. 2/Description of the conditions of use of Flixovate® in infants aged less than 12 months (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent treatments etc.).


Condition or disease
Dermatitis, Atopic

Study Type : Observational
Actual Enrollment : 160 participants
Time Perspective: Retrospective
Official Title: Place of Flixovate® in the Treatment Pathway and Its Conditions of Use in Infants Aged From 3 to 12 Months Between 2010 and 2012 by French GPs and Private Paediatricians
Study Start Date : April 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013



Primary Outcome Measures :
  1. Description of the conditions of use of Flixovate® in infants aged less than 12 months [ Time Frame: baseline ]
    data collected and analysed: Profile of prescribers (age, sex, geographic location), Profile of infants (age, age group, gender, Z-score, medical history), Conditions (diagnoses corresponding to prescriptions of Flixovate®, dosage, mean duration of treatment and duration in classes, previous treatment, concomitant medications, treatments prescribed after discontinuation of Flixovate®. (emollients and other topical steroids).

  2. - Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. [ Time Frame: baseline, one year, 2 years, 3 years ]
    data collected and analysed: Profile of prescribers (age, gender, geographical location). Number of prescriptions of Flixovate® and other topical steroids by class, INN and brand name



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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
retrospective database extraction
Criteria

Inclusion Criteria:

Analysis of changes in share of prescriptions:

  • Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012.
  • Infants aged 3 to 12 months on the day of prescription of topical steroids.

Description of the conditions of use and patient profiles:

  • Infants who received at least one prescription of topical steroids between 1st January 2010 and 31st December 2012.
  • Infants aged 3 to 12 months on the day of prescription of topical steroids.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01920464


Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01920464     History of Changes
Other Study ID Numbers: 116296
First Posted: August 12, 2013    Key Record Dates
Last Update Posted: September 15, 2014
Last Verified: September 2014

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases